Complete Brand Multi-Purpose Solution
FDA 510(k) K030092 · Advanced Medical Optics, Inc.
510(k) numberK030092
Submission
- Device name
- Complete Brand Multi-Purpose Solution
- Applicant
- Advanced Medical Optics, Inc.
Santa Ana, CA, US - Received
- January 10, 2003
- Decision date
- April 4, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPN – Accessories, Soft Lens Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081681 | Vitrectomy Cutter and AccessoriesMLZ · Abbreviated | 10/08/2008SE |
| K081545 | One Series Ultra Cartridge, Model 1VIPR30MSS · Traditional | 10/02/2008SE |
| K060366 | The Amo Ophthalmic Surgical SystemHQC · Abbreviated | 04/07/2006SE |
| K042562 | Lens Plus Rewetting DropsLPN · Abbreviated | 07/29/2005SE |
| K050648 | Sovereign High Vacuum Pack, Sovereign Compact High Vacuum PackHQC · Traditional | 04/05/2005SE |
| K040839 | Complete Blink-N-Clean Lens DropsMRC · Abbreviated | 10/19/2004SE |
| K032030 | Blink CL Lubricant Eye DropsLPN · Traditional | 09/25/2003SE |
Questions and answers
When was Complete Brand Multi-Purpose Solution cleared by the FDA?
Complete Brand Multi-Purpose Solution (K030092) received a 510(k) decision of Substantially Equivalent on April 4, 2003, 84 days after the submission was received.
What is the product code of K030092?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.